NCT04100564已完成不适用
Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jason Sperry
- 入组人数
- 2,010
- 试验地点
- 17
- 主要终点
- 24-hour survival
研究概览
简要总结
The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic injury requiring advanced airway management. Indicators of need for advanced airway management include: a) GCS<8, b) SpO2<90 despite supplemental oxygen, b) ETCO2>60 despite supplemental ventilation, or d) provider discretion.
- •Transport (or intended transport) to an enrolling LITES Trauma Center
排除标准
- •< 15 years of age
- •Known pregnancy
- •Known prisoner
- •Initial advanced airway attempted by a non-PACT provider.
- •Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention
- •Caustic substance ingestion
- •Airway burns
- •Objection to study voiced by subject or family member at the scene.
- •Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle.
- •If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.
研究组 & 干预措施
Standard airway method arm
Active Comparator
Standard airway management strategy
干预措施: Standard airway management (Other)
Supraglottic airway method arm
Experimental
Supraglottic first airway management strategy
干预措施: Supraglottic airway device (Device)
结局指标
主要结局
24-hour survival
时间窗: From injury through 24 hours
次要结局
- ICU length of stay(Admission through 30 days or discharge)
- Ventilator days(Admission through 30 days or discharge)
- Incidence of hypotension(At the time of placement of device through time of arrival to trauma bay)
- Rate of first pass success of placement of advanced airway device(At time of placement of device through confirmation of device placement)
- Incidence of expected adverse events(From initial airway management through first 24 hours of hospital admission)
- Incidence of need for rescue airway device(At the time of placement of device through time of arrival to trauma bay)
- Proportion of subjects that survive to hospital discharge(From hospital admission through death or hospital discharge up to 30 days)
- Incidence of hypoxia(At the time of placement of device through time of arrival to trauma bay)
研究者
研究点 (17)
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